Method and apparatus for providing proportional positive airway pressure to treat congestive heart failure

• US 5,794,615 A
• Filed: 07/15/1996
• Issued: 08/18/1998
• Est. Priority Date: 06/03/1994
• Status: Expired due to Term

• Current Assignee: RIC INVESTMENTS LLC (Respironics Incorporated)
• Original Assignee: Respironics Incorporated
• Inventors: Estes, Mark C.
• Primary Examiner(s): Asher, Kimberly L.
• Application Number:
  US08/679,898
• Time in Patent Office: 764 Days
• Field of Search: 128/204.18, 128/204.21, 128/204.23, 128/204.26
• US Class Current: 128/204.23
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/204 used for inhalation control
• CPC Class Codes: A61M 16/205 used for exhalation control
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit

Abstract

A system including methods and apparatus for treatment of Congestive Heart Failure. The system involves applying separate and independent gains to flow rates of pressurized gas delivered to a patient during inspiratory and expiratory phases of a respiratory cycle to deliver the pressurized gas in proportion to the respective gains during inspiration and expiration. A base pressure may be applied in addition to the gain-modified pressures and an elevated pressure profile may be employed to assist or control inspiration. The system may be fully automated responsive to feedback provided by a flow sensor that determines the estimated patient flow rate. A leak computer can be included to instantaneously calculate gas leakage from the system. The system may be utilized in connection with conventional continuous positive airway pressure (bi-level PAP) equipment to effect various beneficial treatment applications.

Claims

1. A Proportional Positive Airway Pressure apparatus for delivering pressurized breathing gas to the airway of a patient, said apparatus comprising:

means for continuously delivering breathing gas at a minimally sufficient pressure to reduce cardiac preload and afterload at any given moment during at least a portion of a breathing cycle where the minimally sufficient gas pressure may continuously vary during the at least a portion of a breathing cycle and is responsive to a sensed rate of flow of gas, said minimally sufficient gas pressure being the summation of a pressure needed to reduce cardiac preload and afterload in the absence of respiratory loading and a pressure needed to overcome the impact of respiratory loading on cardiac preload and afterload,

gas flow generator means for providing a source of gas;

conduit means for delivering gas to the airway of a patient from said source of gas;

circuitry means for providing a command signal to regulate a pressure controller means;

sensor means for continuously detecting the rate of flow of gas within said conduit means and for continuously transmitting signals to said circuitry means corresponding to said rate of flow of gas within said conduit means;

first control means operatively connected to said circuitry means for selectively establishing a first gain to be applied by said circuitry means to first flow rate signals continuously transmitted by said sensor means to said circuitry means, said first flow rate signals corresponding to flow within said conduit means indicative of inspiration;

second control means operatively connected to said circuitry means for selectively establishing a second gain to be applied by said circuitry means to second flow rate signals continuously transmitted by said sensor means to said circuitry means, said second flow rate signals corresponding to flow within said conduit means indicative of expiration, and

pressure controller means co-operable with said gas flow generator means for delivering said gas flow within said conduit means and within the airway of a patient at said minimally sufficient gas pressure during the at least a portion of a breathing cycle in proportion to both said first gain and said continuously transmitted first flow rate signals during inspiration and in proportion to both said second gain and said continuously transmitted second flow rate signals throughout expiration in response to said command signal.

2. The apparatus of claim 1 further comprising means operatively connected to said circuitry means for selectively establishing a base pressure to be provided by said pressure controller means, said base pressure being provided by said pressure controller means in addition to said gas pressure provided in proportion to said first gain and said first flow rate signals during inspiration and in proportion to said second gain and said second flow rate signals throughout expiration, said base pressure being substantially equivalent to said pressure needed to reduce cardiac preload and afterload in the absence of cardiac loading, and said pressure needed to overcome respiratory loading being proportional to the respective gain.

3. The apparatus of claim 2 further comprising means operatively connected to said circuitry means for selectively establishing an elevated pressure profile to be provided by said pressure controller means during a predetermined initial segment of inspiration.

4. The apparatus of claim 2 further comprising means in signal receiving communication with said sensor means and operatively connected to said first control means and said means for selectively establishing a base pressure for substantially continuously adjusting at least one of said first gain and said base pressure responsive to signals received from said sensor means.

5. The apparatus of claim 3 further comprising means in signal receiving communication with said sensor means and operatively connected to said first control means, said means for selectively establishing a base pressure and said means for selectively establishing an elevated pressure profile for substantially continuously adjusting at least one of said first gain, said base pressure and said elevated pressure profile responsive to signals received from said sensor means.

6. The apparatus of claim 1 further comprising means operatively connected to said circuitry means for selectively establishing an elevated pressure profile to be provided by said pressure controller means during a predetermined initial segment of inspiration.

7. The apparatus of claim 1 further comprising means operatively connected to said pressure controller means for preventing said pressure controller means from providing said flow of gas above a predetermined maximum pressure.

8. The apparatus of claim 1 further comprising means operatively connected to said pressure controller means for preventing said pressure controller means from providing said flow of gas below a predetermined minimum pressure.

9. The apparatus of claim 1 further comprising memory means operatively connected to said circuitry means for measuring and storing information associated with operation of said apparatus.

10. The apparatus of claim 1 further comprising means in signal receiving communication with said sensor means and operatively connected to said circuitry means for substantially instantaneously calculating gas leakage from said apparatus responsive to signals received from said sensor means.

11. The apparatus of claim 1 further comprising means in signal receiving communication with said sensor means and operatively connected to said first control means for substantially continuously adjusting said first gain responsive to signals received from said sensor means.

12. The apparatus of claim 1 further comprising means in signal receiving communication with said sensor means and operatively connected to said circuitry means for transmitting to said circuitry means an inspiratory positive airway pressure signal responsive to said first flow rate signals received from said sensor means and an expiratory positive airway pressure signal responsive to said second flow rate signals received from said sensor means.

13. A method of providing Proportional Positive Airway Pressure to the airway of a patient, said method comprising the steps of:

providing means for continuously delivering breathing gas at a minimally sufficient pressure to reduce cardiac preload and afterload at any given moment during at least a portion of a breathing cycle where the minimally sufficient gas pressure may continuously vary during the at least a portion of a breathing cycle and is responsive to a sensed rate of flow of gas, said minimally sufficient gas pressure being the summation of a pressure needed to reduce cardiac preload and afterload in the absence of respiratory loading and a pressure needed to overcome the impact of respiratory loading on cardiac preload and afterload,

providing a source of gas;

supplying gas to the airway of a patient from said source of gas;

substantially continuously determining the flow rate of gas between said source and the airway of a patient;

applying a first gain to a determined flow rate of gas indicative of inspiration;

applying a second gain to a determined flow rate of gas indicative of expiration; and

delivering said minimally sufficient gas pressure in proportion to said first gain and said determined flow rate during inspiration and in proportion to said second gain and said determined flow rate throughout expiration.

14. The method of claim 13 further comprising the step of:

providing a base pressure of gas in addition to said gas pressure provided in proportion to said first gain and said first flow rate signals during inspiration and in proportion to said second gain and said second flow rate signals throughout expiration, said base pressure being substantially equivalent to said pressure needed to reduce cardiac preload and afterload in the absence of respiratory loading, and said pressure needed to overcome respiratory loading being proportional to the respective gain.

15. The method of claim 14 further comprising the step of:

during inspiration, providing the greater of a selected elevated pressure profile and said gas pressure provided in proportion to said first gain and said first flow rate signals.

16. The method of claim 14 further comprising the step of:

during inspiration, providing a selected elevated pressure profile for a predetermined initial segment of inspiration and providing said gas pressure in proportion to said first gain and said first flow rate signals for the remainder of inspiration.

17. The method of claim 14 further comprising the step of:

substantially continuously adjusting at least one of said first gain and said base pressure responsive to said determined flow rate.

18. The method of claim 14 further comprising the step of:

substantially continuously adjusting at least one of said first gain, said base pressure and a selected elevated pressure profile responsive to said determined flow rate.

19. The method of claim 13 further comprising the step of:

during inspiration, providing the greater of a selected elevated pressure profile and said gas pressure provided in proportion to said first gain and said first flow rate signals.

20. The method of claim 13 further comprising the step of:

during inspiration, providing a selected elevated pressure profile for a predetermined initial segment of inspiration and providing said gas pressure in proportion to said first gain and said first flow rate signals for the remainder of inspiration.

21. The method of claim 13 further comprising the step of:

preventing said gas pressure from being provided above a predetermined maximum pressure.

22. The method of claim 13 further comprising the step of:

preventing said gas pressure from being provided below a predetermined minimum pressure.

23. The method of claim 13 further comprising the step of:

measuring and storing information associated with performance of said method.

24. The method of claim 13 further comprising the step of:

substantially continuously calculating gas leakage responsive to said determined flow rate.

25. The method of claim 13 further comprising the step of:

substantially continuously adjusting said first gain responsive to said determined flow rate.

26. A method of providing Proportional Positive Airway Pressure to the airway of a patient, said method comprising the steps of:

providing means for continuously delivering breathing gas at a minimally sufficient pressure to reduce cardiac preload and afterload at any given moment during expiration where the minimally sufficient gas pressure may continuously vary during expiration and is responsive to a sensed rate of flow of gas, said minimally sufficient gas pressure being the summation of a pressure needed to reduce cardiac preload and afterload in the absence of respiratory loading and a pressure needed to overcome the impact of respiratory loading on cardiac preload and afterload,

providing a source of gas;

supplying gas to the airway of a patient from said source of gas;

substantially continuously determining the flow rate of gas between said source and the airway of a patient;

applying a gain to a determined flow rate of gas indicative of expiration; and

delivering continuous positive airway pressure during inspiration and said minimally sufficient gas pressure in proportion to said second gain and in proportion to said determined flow rate throughout expiration.

27. A method of providing Proportional Positive Airway Pressure to the airway of a patient, said method comprising the steps of:

providing means for continuously delivering breathing gas at a minimally sufficient pressure to reduce cardiac preload and afterload at any given moment during expiration where the minimally sufficient gas pressure may continuously vary during expiration and is responsive to a sensed rate of flow of gas, said minimally sufficient gas pressure being the summation of a pressure needed to reduce cardiac preload and afterload in the absence of respiratory loading and a pressure needed to overcome the impact of respiratory loading on cardiac preload and afterload,

providing a source of gas;

supplying gas to the airway of a patient from said source of gas;

substantially continuously determining the flow rate of gas between said source and the airway of a patient;

applying a gain to a determined flow rate of gas indicative of expiration; and

delivering inspiratory positive airway pressure during inspiration and, throughout expiration, providing expiratory positive airway pressure at a lower pressure than said inspiratory positive airway pressure in addition to gas pressure in proportion to said second gain and said determined flow rate.

28. A method of providing Proportional Positive Airway Pressure to the airway of a patient, said method comprising the steps of:

providing means for continuously delivering breathing gas at a minimally sufficient pressure to reduce cardiac preload and afterload at any given moment during a portion (t₁ to t₀) of a breathing cycle where the minimally sufficient gas pressure may continuously vary during the portion of a breathing cycle and is responsive to a sensed rate of flow of gas, said minimally sufficient gas pressure being the summation of a pressure needed to reduce cardiac preload and afterload in the absence of respiratory loading and a pressure needed to overcome the impact of respiratory loading on cardiac preload and afterload,

providing a source of gas;

supplying gas to the airway of a patient;

substantially continuously determining the flow rate of gas between said source and the airway of a patient; and

delivering gas pressure to the airway of a patient in accordance with the equations;

space="preserve" listing-type="equation">P.sub.inhalation (t.sub.0 to t.sub.1)=IPAP

and

space="preserve" listing-type="equation">P.sub.inhalation (t.sub.1 to t.sub.2)=P.sub.base +AutoGain.sub.Insp *Flow at t.sub.1

and

space="preserve" listing-type="equation">P.sub.exhalation =P.sub.base +Gain.sub.Exp *Flow,

where Flow is the continuously determined estimated flow rate, t₀ is the time at the start of breath, t₁ is the time when the estimated flow rate is a predetermined percentage of peak inspiratory flow rate, t₂ is the time at start of exhalation, IPAP is a continuously applied inspiratory positive airway pressure, P_inhalation (t₀ to t₁) is the pressure delivered to the patient from t₀ to t₁, P_base is a continuous base pressure, AutoGain_Insp equals (IPAP-P_base)/Flow at t₁, P_inhalation t₁ to t₂ is the pressure delivered to the patient from t₁ to t₂, Gain_Exp is the constant used during exhalation to reduce pressure delivered to the patient and P_exhalation is the pressure delivered to the patient throughout exhalation.